PERCIST Evaluation of Trastuzumab Deruxtecan in the Treatment of HER2 Low Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Objective response rate
研究概览
简要总结
The development of trastuzumab deruxtecan (T-DXd), an anti-HER2 conjugated antibody, has changed the therapeutic landscape of breast cancer. Anti-HER2 molecules were previously used exclusively in cases of HER2-positive breast cancer (IHC HER2 3+ or HER2 2+ with amplified FISH/SISH).
Since a couple of years, T-DXd is becoming a reference treatment in patients with low HER2 breast cancer (IHC 1+ or 2+ with non-amplified FISH/SISH) after hormone therapy and at least one line of chemotherapy. The results of the DB04 trial revealed that T-DXd increased progression-free survival and overall survival compared to investigator's choice chemotherapy, in HER2 low breast cancers patients after one or two previous lines of chemotherapy (Modi, S. et al., 2022).
In several trials, T-DXd validation was done thanks to radiological evaluation based on conventional imaging, computed tomography scan (CT-scan) with or without contrast dye injection and bone scintigraphy.
18F-Fluorodeoxyglucose positron emission tomography coupled with computed tomography (18F-FDG PET-CT) represents a major tool for diagnosis, staging, and therapeutic follow-up in oncology.
It was demonstrated that 18F-FDG PET-CT is more sensitive in detecting metastatic disease progression in HER2-positive breast cancer patients treated with trastuzumab and pertuzumab or trastuzumab and lapatinib (Ma, G. et al., 2023 et Lin, N. U. et al., 2015). Moreover, a prospective study investigated the correlation between the response rate defined by 18F-FDG PET-CT and thoraco-abdomino-pelvic CT-scan (TAP CT-scan) and the progression-free survival of patients with breast cancer. PET evaluation allowed better identification of responders versus non-responders, with a significant correlation with progression-free survival (Vogsen, M. et al., 2023).
With this study, the investigators aim to determine the role of 18F-FDG PET-CT in evaluating T-DXd treatment in patients with metastatic low HER2 breast cancer. 18F-FDG PET-CT could be an earlier evaluation tool than CT-scan in identifying non-responsive patients; and thus, avoid continuing an expensive treatment with an unfavorable toxicity profile, which could worsen both patient prognosis and quality of life.
详细描述
Screening period will last 28 days. Each participant will have baseline evaluation by TAP CT-scan, bone scintigraphy and 18F-FDG PET-CT.
After randomization, patient will start T-DXd treatment according to SOC until progression or toxicity. Patient will be followed by TAP CT-scan and bone scintigraphy (SOC arm) or 18F-FDG PET-CT (experimental arm) every 3 months, until progression or new treatment initiation or death or until 2 years whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years at inclusion
- •Cytological or histological confirmation of the diagnosis of low HER2 breast cancer (IHC 1+ or 2+ with non-amplified FISH/SIS)
- •Metastatic disease according to RECIST 1.1
- •Indication of T-DXd treatment
- •Patient (male or female of childbearing potential) using a highly effective contraceptive method
- •Women of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment
- •Willingness and ability to comply with the visit schedule, treatment regimens, examinations and other procedures planned in the study
- •Patient enrolled in a health insurance plan or beneficiary of such a plan
- •Signed informed consent obtained before inclusion (after giving clear, fair and appropriate information)
排除标准
- •Allergy to contrast dye
- •Contra-indication to PET-CT
- •Any active infection or uncontrolled intercurrent pathology
- •Patient with a life expectancy lower than 3 months
- •Ongoing participation in another clinical trial with an investigational treatment
- •Pregnant or breastfeeding women
- •Persons deprived of their freedom or under guardianship or incapable of giving consent
- •Any psychiatric illness/social situation that may limit compliance with study procedures or prevent the patient from giving written informed consent
结局指标
主要结局
Objective response rate
时间窗: at 3 months
Radiological response according to PERCIST 1.0 criteria in experimental arm and RECIST 1.1 criteria in SOC arm. Number of patients who had an objective response at 3 months in both arms. The evaluation is carried out by the investigator.
次要结局
- Progression-free survival(Every 3 months until the date of first documented progression or new therapy initiation or date of death or until 2 years, whichever occurs first.)
- Time until new therapy initiation(Until initiation of a new therapy or until 2 years, whichever occurs first.)
- Overall survival(From date of inclusion until the date of death or lost to follow-up or until 2 years, whichever occurs first.)
- Response duration(Every 3 months until the date of first documented progression or new therapy initiation or date of death or until 2 years, whichever occurs first.)
- Patient Quality of life(Every 3 months until the date of first documented progression or new therapy initiation or date of death or until 2 years, whichever occurs first.)
- Progression-free survival(Every 3 months until the date of first documented progression or new therapy initiation or date of death or until 2 years, whichever occurs first.)
- Time until new therapy initiation(Until initiation of a new therapy or until 2 years, whichever occurs first.)
- Overall survival(From date of inclusion until the date of death or lost to follow-up or until 2 years, whichever occurs first.)
- Response duration(Every 3 months until the date of first documented progression or new therapy initiation or date of death or until 2 years, whichever occurs first.)
- Patient Quality of life(Every 3 months until the date of first documented progression or new therapy initiation or date of death or until 2 years, whichever occurs first.)